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Trial ID CA057-003  |   NCT05372354

A Study to Evaluate Safety, Drug Levels and Effectiveness of CC-92480 (BMS-986348) in Combination With Other Treatments in Participants With Relapsed or Refractory Multiple Myeloma

Summary

  • Phase 1/Phase 2
  • Male and Female Gender icon
  • 18+
    Age Range
  • 12
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

The purpose of this study is to assess the safety, tolerability and preliminary effectiveness of CC-92480 (BMS-986348) in novel therapeutic combinations for the treatment of Relapsed or Refractory Multiple Myeloma (RRMM).

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • Relapsed or refractory multiple myeloma (MM) and must: 1. have documented disease progression during or after their last myeloma therapy 2. be refractory to, intolerant to, or not a candidate for available, established therapies known to provide clinical benefit in MM
    1. Must have measurable disease
      1. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
        1. Agree to follow the CC-92480 Pregnancy Prevention Plan (PPP)

          Exclusion Criteria

          Exclusion Criteria Icon
          :
          • Known active or history of central nervous system (CNS) involvement of MM
            1. Plasma cell leukemia; Waldenstrom's macroglobulinemia; polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS) syndrome; or clinically significant light-chain amyloidosis.
              1. Impaired cardiac function or clinically significant cardiac disease
                1. Previous SARS-CoV-2 infection within 14 days for asymptomatic or mild symptomatic infections or 28 days for severe/critical illness prior to Cycle 1 Day 1 (C1D1)
                  1. For Part 1: received prior therapy with CC-92480
                    1. For Part 2: received prior therapy with CC-92480, tazemetostat, BMS-986158, or trametinib
                      1. Previously received allogeneic stem-cell transplant at any time or received autologous stem-cell transplant within 12 weeks of initiating study treatment
                        1. Received any of the following within 14 days prior to initiating study treatment: 1. Plasmapheresis 2. Major surgery 3. Radiation therapy other than local therapy for myeloma associated bone lesions 4. Use of any systemic anti-myeloma drug therapy
                          1. Used any investigational agents within 28 days or 5 half-lives (whichever is shorter) prior to initiating study treatment
                            1. COVID-19 vaccine within 14 days prior to C1D1 Other protocol-defined inclusion/exclusion criteria apply
                              Additional Information *

                              Treatment Options

                              Study Arms

                              ASSIGNED INTERVENTION

                              Study Arms

                              Experimental: Part 1 Arm A: Dose Finding

                              ASSIGNED INTERVENTION
                              • Drug: CC-92480, Tazemetostat, Dexamethasone

                              Study Arms

                              Experimental: Part 1 Arm B: Dose Finding

                              ASSIGNED INTERVENTION
                              • Drug: CC-92480, BMS-986158, Dexamethasone

                              Study Arms

                              Experimental: Part 1 Arm C: Dose Finding

                              ASSIGNED INTERVENTION
                              • Drug: CC-92480, Trametinib, Dexamethasone

                              Study Arms

                              Active Comparator: Part 2 Arm D: Dose Expansion

                              ASSIGNED INTERVENTION
                              • Drug: CC-92480, Dexamethasone

                              Study Arms

                              Experimental: Part 2 Arm E: Dose Expansion

                              ASSIGNED INTERVENTION
                              • Drug: CC-92480, Tazemetostat, Dexamethasone

                              Study Arms

                              Experimental: Part 2 Arm F: Dose Expansion

                              ASSIGNED INTERVENTION
                              • Drug: CC-92480, BMS-986158, Dexamethasone

                              Study Arms

                              Experimental: Part 2 Arm G: Dose Expansion

                              ASSIGNED INTERVENTION
                              • Drug: CC-92480, Trametinib, Dexamethasone
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